LTC Research Influencing Practice

Transcription

1 LTC Research Influencing Practice David A. Nace, MD, MPH Division of Geriatric Medicine PGS Clinical Update April 6, 2017

2 Conflicts of Interest Dr. Nace does not have any current conflicts of interest to report.

3 Objective Discuss five articles that have the potential to change LTC practice.

4 Methods 5 LTC focused articles Potential practical implications Selection period Sept 2015 to Sept 2016 English language Identified using an expanding search strategy Top rank medicine journals > JAMDA & JAGS > OVID Core > Pub Med

5 What Do I Do with Those Dementia Medications? Do I Continue the Cholinesterase Inhibitor? Do I Add Memantine?

6 Current State of Knowledge Cholinesterase Inhibitors (ACI) in NF What We Know NF Residents w/dementia Increased AD severity Greater functional impairment What We Don t Benefits in NF Population Risks of Drug Withdraw in NF Residents More medications

7 ACI do not impact mortality ACI do not increase survival ACI are not disease modifiers ACI have limited benefit Temporary stabilizers

8 A Randomized Placebo-Controlled Discontinuation Study of Cholinesterase Inhibitors in Institutionalized Patients with Moderate to Severe Alzheimer Disease Herrmann N, O Regan J, Ruthirakuhan M, Kiss A, Eryavec G, Williams E, Lanctot KL. J Am Med Dir Assoc 2016;17(2):

9 Design 8 week placebo controlled, double-blind RCT Continued ACI vs ACI withdrawal 2 NF in Canada Inclusion criteria >55 yr with probable AD 15 on MMSE 2 years on donepezil, rivastigmine, galantamine ACI dose stable 3 mos Concomitant psychotropics stable 1 mos

10 Outcome Measures Clinicians Global Impression Clinicians Global Impression of Change (CGIC) MMSE Severe Impairment Battery Udvalg (side effects) Neuropsychiatric Inventory- NH Cornell Depression Scale for Dementia Apathy Evaluation Scale Cohen-Mansfield Agitation Inventory ADCS-ADL-sev QUALID (QOL) CGIC primary outcome

11 Results 40 subjects with moderate to severe AD No significant difference in CGIC decline 6 worsened in continuation grp 7 worsened in withdrawal grp Baseline hallucinations predicted CGIC decline Baseline delusions trended to predict CGIC decline No difference in adverse event rates No difference in other measures

12 Results Limitations Sample size Duration of follow up = 6 weeks Mostly male population Differs from meta-analysis by same authors of 5 studies of ACI withdraw among community dwellers Mostly earlier stage disease

13 Summary ACI discontinuation is safe and well tolerated in NF residents with moderate to severe AD who have been stable, and treated for 2 yrs without psychotic features (hallucinations/delusions) at baseline Supports prior work showing ACI can attenuate behavioral symptoms

14 Criteria for Attempting ACI Withdraw Does the resident have moderate to severe dementia? Has the resident been on an ACI for 2 years? Has the ACI dose been stable 3 months? Is the resident free of psychotic features (hallucinations, delusions)? Have other psychotropic medications been stable 1 month? Yes No ACI = acetylcholinesterase inhibitor

15 Current State of Knowledge Combination Therapy with Memantine What We Know Memantine approved for moderate to severe AD ACI approved for all stages of AD Conflicting results for combination therapy trials What We Don t Are there benefits with combination therapy?

16 Combination Therapy Showed Limited Superiority Over Monotherapy for Alzheimer Disease: A Meta-analysis of 14 Randomized Trials Tsoi KKF, Chan JYC, Leung NWY, Hirai HW, Wong SYS, Kwok TCY. J Am Med Dir Assoc 2016;17(9):863.e1-863.e8.

17 Design Meta-analysis through 2015 Study inclusion criteria RCT Alzheimer Disease Compared effectiveness of combination therapy against monotherapy Measured change in assessment scores, or adverse events, from baseline to study endpoints Full text and details available Included advanced dementia stages

18 Results 4485 abstracts identified 14 studies eligible 7 > moderate to severe 7 > mild to moderate 5019 patients 42% male years of age Baseline MMSE 9-21

19 Outcomes Cognition MMSE (Monotherapy with NMDA) MMSE (Monotherapy with ACI) MMSE (Any Monotherapy) Function ADCS-ADL (Monotherapy with NMDA) ADCS-ADL (Monotherapy with ACI) ADCS-ADL (Any Monotherapy) Mean Difference , , , , , , % CI Significant? NS NS NS NS NS NS

20 Outcomes Neuropsychiatric & Behavior NPI (Monotherapy with ACI) Global Changes CIBIC-plus (Monotherapy with ACI) Mean Difference , , % CI Significant? NS* NS Adverse events not different *Combination therapy was better on neuropsychiatric and behavior symptoms when restricted to studies of moderate to severe AD (excluding the mild to moderate AD studies)

21 Summary Combination therapy beneficial on neuropyschiatric and behavioral symptoms in those with moderate to severe disease No clear benefit to combination therapy in for other outcomes No major adverse events with combination therapy compared to monotherapy Combination therapy increases costs with limited benefit in most cases

22 Summary Careful assessment of individuals with moderate to severe disease In absence of behavioral and psychological symptoms of dementia, combined therapy not likely to benefit Combined therapy not likely to benefit those with mild to moderate disease

23 What Is This Patient s Risk of 30 Day Readmission? Who Should I Follow More Closely?

24 Current State of Knowledge 30 Day Readmissions What We Know 20% of hospitalized Medicare pts are discharged to SNFs 23.5% of these are readmitted w/i 30 days SNF transfers have greater severity of illness c/w community discharges What We Don t No prediction tools for patients discharged to SNFs HOSPITAL Score developed, but not validated for SNF patients

25 Validation of the HOSPITAL Score for 30-Day All- Cause Readmissions of Patients Discharged to Skilled Nursing Facilities Kim LD, Kou L, Messinger-Rapport BJ, Rothberg MB. J Am Med Dir Assoc 2016;17(9):863.e e18.

26 Design Validation study HOSPITAL score developed in Boston Retrospective collection of administrative and clinical data Outcome was readmission w/i 30 days to Cleveland Clinic Health System hospital Variable was HOSPITAL score

27 HOSPITAL Score Attribute Points Hemoglobin < 12 g/dl at discharge 1 Discharge from oncology service 2 Na < 135 meq/l at discharge 1 Any ICD9 coded procedure 1 Non-elective admission 1 Number hospital admissions in prior yr >5 5 Length of stay 5 days 2 Total = (Low Risk = 0-4; Intermediate Risk = 5-6; High Risk = 7)

28 Results 4208 discharges Mean age = % = African American Medicare primary payor = 75% 30-day readmit rate = 30.9%

29 Results 45.00% 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% 40.90% 28.10% 15.40% Low Risk Intermediate Risk Hi Risk c-statistic = 0.65

30 Summary HOSPITAL Score stratifies NF patients regarding all-cause 30-day readmission risk Can be used by clinicians to identify those who may need extra attention in order to prevent readmissions Helpful given SNF VPB, 5 Star Measures, & narrowed network providers

31 Long Acting Opioids & Long Stay Residents Always Start the Game in the First Inning

32 Current State of Knowledge Long Acting Opioids (LAO) What We Know LAO opioids should not be started in opioid naïve patients FDA warnings, particularly about fentanyl patches In , 39% of RI NF residents started on LAO had not used any opioid in prior 60 days What We Don t What is happening nationally with LAO prescribing? Has there been any improvement in LAO prescribing?

33 New Initiation of Long-Acting Opioids in Long- Stay Nursing Home Residents Pimentel CB, Gurwitz JH, Tjia J, Hume AL, Lapane KL. J Am Geriatr Soc 2016; Aug 3. doi: /jgs (epub ahead of print)

34 Design Analysis of NF residents via 4 national data sets Long stay NF residents (> 90 d) Minimize Part A covered meds Minimize uncaptured acute care meds Jan 1 to Dec 31, ,253 met inclusion criteria Opioid naïve = no short acting opioid w/i 60 days

35 Results Mean age = 75, 71% female 73% mild to mod functional impairment 19% mod to severe cognitive impairment 83% had pain in prior 5 days 25% had constant pain 45% had frequent pain 26% had occasional pain

36 Results 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% When LAO Are Prescribed Following Admission 81% 72% 55% 31% 7 Days 30 Days 60 Days 90 Days

37 New Initiation of LAO in Long Stay Nursing Home Residents By Look Back Period Overall 9.4% of LAO Prescriptions W/I 30 days Were in Opioid Naïve Patients J Am Geriatr Soc 2016;64(9):

38 Results Most Common Long Acting Opioids Started in Opioid Naïve Residents 2.7% 17.2% 28.2% 51.9% Fentanyl Patch Morphine Oxycodone Others

39 Summary Rate of LAO use in opioid naïve residents may be declining BUT > 9% of NF residents started on LAO in the first 30 days are opioid naïve 18.5% of NF residents prescribed LAO at any point, are opioid naïve Fentanyl patches comprise the largest category of potentially inappropriate LAO starts May be particularly true in hospice patients

40 Delusions About Reducing Antipsychotics Can We Really Make a Difference?

41 Current State of Knowledge Antipsychotic (AP) Review What We Know Behavioral problems impact 90% of patients w/dementia AP medications have modest benefits, but also significant risks AP usage should be regularly reviewed and dose reductions attempted What We Don t Is AP review effective in reducing AP use? Can nonpharmacological interventions reduce agitation among residents with dementia? Does exercise reduce depression?

42 Impact of Antipsychotic Review & Nonpharmacological Intervention on Antipsychotic Use, Neuropsychiatric Symptoms, & Mortality in People with Dementia Living in Nursing Homes: A Factorial Cluster-Randomized Controlled Trial by the Well-Being & Health for People with Dementia (WHELD) Program Ballard C, Orrell M, YongZhong S, Moniz-Cook E, et al. Am J Psychiatry 2016;173(3):

43 Design Cluster randomized 9 month trial in 16 NF Residents with stage 4 dementia or greater 8 NF assigned to AP review 8 NF assigned to increased social interaction 8 NF assigned to exercise intervention All received person centered care training Outcomes Primary = AP use. Secondary = Mortality & Neuropsych measures

44 Results 277 participants 195 (70%) completed the study Mean age = 85, Female = 74% Dementia (CDR) Severity Mild 12% Mod 40% Sev 47% 18% were taking AP

45 Results AP Review No AP Review Number on AP at Start Number Discontinued 10 0 New AP Starts 3 3 Final AP Use % reduction over 9 months 3 residents discontinued had worsening of NPI scores, but these residents had baseline scores above 14

46 Results No AP Review or Social Interaction Mortality 35% AP Review 28% AP Review and Social Interaction 19% In regression analysis, strongest association with mortality was social interaction. Exercise did not impact mortality

47 Results AP Review alone had worse NPI scores However, 3 residents were above 14 at baseline Group with AP Review & Social Interaction did not worsen Exercise improved NPI scores, but not depression

48 Summary AP Review effective >>> reduced AP use by 50% Even in population with low prevalence of AP use at baseline (18%) Mortality reduced with AP Review and Social Interaction Social Interaction didn t improve agitation or total NPI scores Exercise helped NPI scores, but not depression

49 Summary AP review is effective and should be part of a facility QAPI program May be harder in facilities with lower rates of AP use, but still worth attempting Non-pharmacological interventions complement AP review efforts, particularly when AP use is low